New patient tools needed to reliably report side effects in chemotherapy clinical trials

PORTLAND, Ore. -- Almost half the symptoms experienced by patients enrolled in chemotherapy clinical trials are not reported by their clinician, according to a study conducted by Oregon Health & Science University Cancer Institute researchers.

"Our data suggest that clinician assessment alone should not be relied upon in reporting side effects in chemotherapy clinical trials," said Tomasz M. Beer, M.D., director of the Prostate Cancer Program in the OHSU Cancer Institute and principal investigator of the study. "If verified, these findings strongly suggest that new tools for patient reporting of symptoms should be developed for use in chemotherapy clinical trials."

Physicians and study nurses routinely identify and report adverse events in chemotherapy clinical trials, yet their accuracy in assessing symptoms is not known. In many other areas of medical research, the patient report is the gold standard for assessing side effects, but this approach has not been routinely incorporated into cancer chemotherapy research.

In one of the first studies of its kind, Erik K. Fromme, M.D., senior scholar in the OHSU Center for Ethics in Health Care joined Beer and colleagues in an effort to determine if clinician reporting of adverse symptoms in chemotherapy clinical trials is reliable. Using a validated questionnaire, researchers compared patient reporting of eight symptoms with a physician's reporting of the same symptoms in the study's adverse events log. The study was presented on June 7, 2004, at the American Society for Clinical Oncology annual meeting in New Orleans, La.

"Our data shows that the physician missed about half the symptoms reported by patients and that patients missed about half the symptoms recorded by the physician," Beer said. "Because physician reporting and patient reporting both identified potentially important symptoms the other did not, patient self-reporting should complement rather than replace physician assessment."

Thirty-seven men with metastatic androgen independent prostate cancer enrolled in a phase II clinical trial of weekly calcitriol and docetaxel participated in the study. They completed a questionnaire every four weeks for up to 28 weeks.

The questionnaire was developed to measure quality of life in cancer patients. Twelve of its 30 questions are devoted to eight symptoms common among cancer patients. These symptoms include fatigue, appetite disturbance, pain, diarrhea, sleep disturbance, shortness of breath, constipation, and nausea and vomiting. Patient compliance with the questionnaires was 94 percent.

Using the questionnaire as the standard, the physician missed 50 out of 104 -- or 48 percent -- of symptoms. Forty-eight symptoms were detected by the physician alone. Forty-nine new or worsened symptoms were detected by both the physician and patients. Fifty-five new or worsened symptoms were detected by patient reporting alone. Overall, physician sensitivity was 47 percent and specificity was 68 percent, although it varied considerably among symptoms.

Symptoms most often missed by the physician, but identified by the patient, were shortness of breath and appetite disturbance. The symptoms most often identified by both the physician and patients were nausea and vomiting, diarrhea and fatigue.

Overall, uncorrected agreement on symptoms was about 59 percent. "Agreement of 59 percent sounds good until you realize the physician and patient should agree 50 percent of the time simply due to chance," Beer said. "Once we corrected for chance, we found only slight agreement on symptoms."

Prostate cancer is the most common cancer in men and the second leading cause of cancer-related death in American men. Overall, one in six men will develop prostate cancer during his lifetime.

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Particulars: ASCO Abstract # 8022, How good is physician reporting of chemotherapy adverse effects? A comparison to patient reported symptoms from the QLQ-C30

Tomasz M. Beer, M.D., assistant professor of medicine (hematology and medical oncology) in the OHSU School of Medicine and director of the Prostate Cancer Program in the OHSU Cancer Institute.

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